Viral hepatitis C is treated with peg-interferon alpha 2a/2b and ribavirin. There is no treatment recommended for non responders patients. This study will evaluate the efficacy, after a second treatment with peg-interferon alpha 2a and ribavirin for 12 Weeks of the addition of interferon gamma in non responders patients

Pilot Study on Interferon Gamma in Association With Peg-Interferon Alpha 2a and Ribavirin Among Patients With a Chronic Hepatitis C and Non Responders to the Association of Peg-Interferon Alpha 2b or 2a and Ribavirin ANRS HC16 Gammatri

Viral hepatitis C is treated with peg-interferon alpha 2a/2b and ribavirin for 24 Weeks. In many patients, there is no efficacy of this treatment on hepatitis C, and there is no treatment recommended for them. Interferon gamma has anti-infectious and anti-fibrosis activity. This study will evaluate the effect, after a second treatment with peg-interferon alpha 2a and ribavirin for 12 Weeks, of the addition of interferon gamma in non responders patients. 65 patients will be included in order to include 27 patients who are non responders after 12 weeks of a second treatment and are eligible to receive interferon gamma. Patients will then receive peg-interferon alpha 2a (180 micro g once a week, by injection), ribavirin (1,000 to 1,200 mg per day, according to weight) and interferon gamma (100 micro g thrice a week, by injection) during 8 months

Non responder to the previous treatment with Peg-interferon alpha 2b and ribavirin, with detectable HCV RNA at W24 or decrease of less than 2 log10 copies/ml at W12 or decrease greater than 2 log10 but detectable HCV RNA

Metavir over F2 on the most recent biopsy

ALT increase over normal value twice during last 6 months

Exclusion Criteria:

HIV infection

Psychiatric pathology

Alcool consummation

Cirrhosis

Pregnancy or plan of pregnancy

Breastfeeding

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00148863

Locations

France

Hopital Haut Leveque Service d'Hepato-Gastro-Enterologie

Pessac, France, 33604

Hôpital du Haut-Levêque

Pessac, France, 33604

Sponsors and Collaborators

French National Agency for Research on AIDS and Viral Hepatitis

InterMune

Hoffmann-La Roche

Investigators

Principal Investigator:

Patrice Couzigou, MD, PhD

Hôpital du Haut-Lévêque, Pessac, France

Study Director:

Geneviève Chêne, MD, PhD

INSERM U593, Bordeaux, France

More Information

No publications provided by French National Agency for Research on AIDS and Viral Hepatitis